Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, preventive maintenance (PM) documentation, fifteen patient records, and interviews with the pathology manager and staff, it was determined that the laboratory failed to ensure performed tests and function checks were documented or maintained prior to patient testing. The findings include: 1. The laboratory performed Mohs micrographic skin cancer surgeries and had an internal Mohs technician team responsible for the technical component and related documentation. The acceptable range for the cryostat equipment was between -27C to -18C wherein the laboratory either failed to document on specific dates or used the cryostat equipment when it was at an out-of- range temperature. 2. The surveyor reviewed fifteen Dermatopathology patient testing records and found that the laboratory used more than one cryostat equipment but no designation was indicated for which was used on a specific patient case. A total of three records were found to be documented in an out-of-temperature, while two other records had missing entries. The discrepancies are as followed: a. Out-of-range temperature: i. Patient 1, SDXS23-9826, examined on 3/30/2023 at -28C. ii. Patient 6, SMAS24-6769, examined on 4/18/2024 at -14C. iii. Patient 14, SMAS24-17236, examined on 10/8/2024 at -28C. b. Missing temperature entries: i. Patient 13, SMAS24-12602, examined on 7/23/2024 ii. Patient 15, SMAS24-12599, examined on 7/23/2024 3. Further review of the laboratory's "Daily Maintenance and Inspection for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (YEAR)" revealed that the almost the entire month of July 2024 was missing entries and patient blocks were processed. Since there was no indication in the reports for which equipment was used for specific cases, the laboratory was unable to verify. In addition, the succeeding months from August to December 2024 had every single entries for cryostat with an out-of range temperature for the HM550, SN30836. 4. No